Study of LJP 394 in Lupus Patients With History of Renal Disease (ASPEN)

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To determine whether abetimus sodium is more effective than placebo in delaying the time to renal flare in SLE patients with a history of SLE renal disease. Weekly administration with a 52-week treatment duration. [ Time Frame: Time to event (12 months fixed treatment duration) ]

Secondary Outcome Measures :

To determine whether treatment with abetimus sodium is more effective than placebo in delaying the time to Major SLE flare; and to determine whether treatment with abetimus sodium (LJP 394) is more effective than placebo in reducing proteinuria. [ Time Frame: 12 month fixed treatment duration ]

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Ages Eligible for Study:

12 Years to 70 Years (Child, Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Diagnosis of Systemic Lupus Erythematosus (SLE)

Active SLE renal disease within past 4 years.

Males or females between 12 and 70 years old.

Females must be non-pregnant and non-lactating. Females and males must use adequate birth control methods during course of study.

Ability to have weekly intravenous (IV) administration of study treatment.